(64 days)
Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:
· Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- · Treatment of Pseudofolliculitis barbae (PFB).
- · Use on all skin types (Fitzpatrick I-VI)
The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).
The provided text is a 510(k) summary for the Eneka Pro device. It describes the device, its indications for use, and its substantial equivalence to a predicate device (Primelase). However, it explicitly states "No clinical studies were conducted as part of this submission" and does not include performance data or acceptance criteria that would typically be found in a clinical study report.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample size, ground truth, experts, and adjudication methods is not available in the provided document.
Here's the information that can be extracted or derived from the text:
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A table of acceptance criteria and the reported device performance
- Not available. The document does not provide a table with specific acceptance criteria or quantitative performance metrics from a study. It only lists general "Performance Testing" which included electrical safety, EMC, laser safety, biocompatibility, and software V&V.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. Since "No clinical studies were conducted," there is no test set of patients or associated provenance information.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available. Without clinical studies, there was no need for experts to establish ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. Not applicable as no clinical studies were performed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not available. This device is a laser hair removal system, not an AI-assisted diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device, not an algorithm, so "standalone" performance in the AI context does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. No clinical studies, therefore no ground truth was established from patient data. The "Performance Testing" mentioned refers to engineering and safety standards, not clinical outcomes.
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The sample size for the training set
- Not applicable / Not available. This is a physical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.
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How the ground truth for the training set was established
- Not applicable / Not available. As above, no training set for an algorithm was used.
Summary of available information regarding performance:
The document states: "Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended." These activities included:
- IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
- IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- Software verification and validation testing in accordance with FDA's Guidance for Premarket Submissions for Software Contained in Medical Devices.
The conclusion is based on substantial equivalence to the predicate device (Primelase) and the successful completion of these non-clinical performance and safety tests, rather than clinical efficacy data.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.